Senior Medical Laboratory Scientist (Quality Control Team Lead), NCIS

Senior Medical Laboratory Scientist (Quality Control Team Lead), NCIS Job ID: 7587 Job Function: Allied Health Institution: National University Hospital Overview NCIS is establishing a new Stem Cell Therapy Hub (SCTH) as part of its expansion of its Specialised Programmes and to become a Reference Centre of Excellence. We are looking for a Quality Control (QC) Team Lead for the QC department in the organisation. The candidate will be responsible for overseeing the Quality Control designated function which can include these areas - Raw Material Testing, In-process testing, Final Product Testing, Analytical Science and Technology, Environmental and QC Systems, for NCIS Specialised Programmes (specifically Cellular Therapy and Haematopoietic Stem Cell Transplant) and other provided services. Job Responsibilities* Lead and direct the assigned Quality Control designated function. As Subject Matter Expert in assigned QC systems/processes/equipment, oversee the implementation and management of systems/processes. Own QC related policies and procedures of the assigned QC processes which include product testing, materials testing, environmental monitoring, method development/qualification/validation, lab investigations, stability testing, LIMS, lab equipment qualification and/or calibration. Ensure timely completion of assigned activities including testing, method development/qualification/validation, equipment qualification or computer systems validation as per agreed lead-time/milestones. Initiate/Review/approve procedures, documents, records, deviations, investigations, corrective action/preventive actions, change controls and gaps assessment associated with the QC area(s) assigned. Ensure QC personnel are qualified and trained to perform assigned tasks. Support product/materials testing, methods qualification/validation activities, equipment qualification activities or other QC related activities as an executor, reviewer and/or approver. Ensure products are tested and assessed per applicable current GxP and regulations. Ensure that facilities, equipment, materials, processes and procedures that are applicable to QC comply with applicable, current GxP and regulations. Manage performance and development of direct reports to ensure achievement of organizational goals. Support improvement initiatives, programs and projects driven from the Quality Management System. Escalate quality and compliance risks to QC and QA Management. Note: Other responsibilities may be assigned by Head of Quality, or senior management. Requirements Bachelor or higher in Science, Pharmacy, Pharmaceutical Science, or equivalent, with preference for more than 6 years of relevant work experience in a Quality Assurance Lead role in the pharmaceutical/biotechnology/medical device/healthcare industry, preferably with increasing people management responsibilities. Extensive knowledge in Quality Management System concepts. Extensive knowledge in regulations and industrial guidance especially for stem cell/cell and gene therapy. Excellent communication skills and ability to engage stakeholders effectively from different functional units. Critical thinking and problem-solving skills are advantageous. #J-18808-Ljbffr